Ribavirin
These highlights do not include all the information needed to use RIBAVIRIN TABLETS safely and effectively. See full prescribing information for RIBAVIRIN TABLETS. RIBAVIRIN tablets, for oral useInitial U.S. Approval: 2002
Approved
Approval ID
08992c51-8fe9-4d37-85cc-42ff337bda00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ribavirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-046
Application NumberANDA077094
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ribavirin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
RIBAVIRINActive
Quantity: 200 mg in 1 1
Code: 49717AWG6K
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Ribavirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-129
Application NumberANDA077094
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ribavirin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (12)
RIBAVIRINActive
Quantity: 600 mg in 1 1
Code: 49717AWG6K
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Ribavirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-127
Application NumberANDA077094
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ribavirin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
RIBAVIRINActive
Quantity: 400 mg in 1 1
Code: 49717AWG6K
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Ribavirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-128
Application NumberANDA077094
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ribavirin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (12)
RIBAVIRINActive
Quantity: 500 mg in 1 1
Code: 49717AWG6K
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT